Roles: System Lifecycle Management

Reviews and approves Functional Specifications and Configuration Specifications in SOLMAN Focused Build. Participates in Work Package management per SolMan ALM Solution Documentation. Approves URS by moving it from Ready for Approval to Approved.

Cross-functional team with collective skills to create a validated Product Increment in an Agile GxP context as defined in SRD-0145688. Accountable as a whole for design, build, testing, risk assessment per user story, and meeting the Definition of Done. Skills span architecture, business analysis,

Owns the IT Infrastructure Qualification SOP and is responsible for maintaining the qualification process definition, ensuring alignment with CSV Lifecycle Directive requirements, and overseeing process improvements.

Owns the Solution Architecture process, responsible for driving design of technology solutions by bringing together functional and non-functional requirements with business, data, technology, and application inputs according to agreed quality standards.

Schedules and performs the Periodic Review of GxP Computerised Systems in ServiceNow IRM. Acts as Engagement Lead, planning the review with stakeholders, completing all Control Tests with justifications, managing the approval workflow, and documenting results. Defined in WI-0300929 Section 4.

Owns the Release Management, Build Management, and Source Control processes, responsible for product release composition, software build assembly, and version-controlled source code management across GxP and ICFR regulated environments.

Owns the Requirement Management and Defect Management processes, responsible for managing requirements from gathering through documentation and tracking defects including their origin, status, severity, and resolution.

Owns the Test Management process, responsible for defining and executing test plans to substantiate system needs and design, and validating key controls against regulated processes.

Sets up Process Steps (L5) and Processes (L4) with GxP relevance, Business Criticality, and Solution Type values for Functional Risk Assessment. Drafts Functional Specifications and Configuration Specifications. Manages Defect Correction objects through Created→Being Corrected→Confirmed→Closed lifec

Approves Technical Operating Procedures (TOPs) together with the Document Owner. Identified by the Document Owner as a required approver to ensure system-level accountability.

Creates and manages Test Plans through their full lifecycle in SOLMAN (Created→Ready for Approval→Approved for Execution→Released for Execution). Executes and closes test runs during SAT/UAT execution phases.

Drafts, reviews, and approves SAT/UAT Test Cases (Test Scripts) in SOLMAN using the 4-eyes principle. Provides information required for defect resolution by managing the Information Required→Information provided→In process defect transitions.

Creates the test strategy for a computerised system based on the implementation risk assessment, and is responsible for executing, managing defects, and reporting on acceptance testing activities.

Manages defect status transitions during test execution in SOLMAN, moving defects from New or Tester Action to In progress or Confirmed and managing Solution Proposal transitions. Participates in Work Package management per SolMan ALM Solution Documentation.

Leads CSV deliverable lifecycle management in SOLMAN Focused Build. Reviews and approves URS, FS, DS, Work Packages, Test Plans, Test Cases, and Defects. Creates Release summaries for IT4IT systems and sets CSV review status. Reviews ChaRMs for adherence to ASPIRE SolMan ALM methodology and verifies